A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age
Phase of Trial: Phase III
Latest Information Update: 05 Apr 2018
At a glance
- Drugs V 270 (Primary) ; Hepatitis B vaccine recombinant
- Indications Hepatitis B
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Dynavax Technologies
- 05 Apr 2018 Results assessing safety of hepatitis B vaccine by using data from three phase III studies including this study published in the Vaccine.
- 27 Dec 2017 Results assessing immunogenecity published in the Vaccine.
- 09 Nov 2017 According to a Dynavax Technologies media release, the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History